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Film coatings for oral pulsatile release

Maroni, Alessandra, Zema, Lucia, Loreti, Giulia, Palugan, Luca, Gazzaniga, Andrea·2013·International Journal of Pharmaceutics
DOI 10.1016/j.ijpharm.2013.03.010
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Abstract

Pulsatile delivery is generally intended as a release of the active ingredient that is delayed for a programmable period of time to meet particular chronotherapeutic needs and, in the case of oral administration, also target distal intestinal regions, such as the colon. Most oral pulsatile delivery platforms consist in coated formulations wherein the applied polymer serves as the release-controlling agent. When exposed to aqueous media, the coating initially performs as a protective barrier and, subsequently, undergoes a timely failure based on diverse mechanisms depending on its physico-chemical and formulation characteristics. Indeed, it may be ruptured because of the gradual expansion of the core, swell and/or erode due to the glassy-rubbery polymer transition or become permeable thus allowing the drug molecules to diffuse outwards. Otherwise, when the coating is a semipermeable membrane provided with one or more orifices, the drug is released through the latter as a result of an osmotic water influx. The vast majority of pulsatile delivery systems described so far have been prepared by spray-coating, which offers important versatility and feasibility advantages over other techniques such as press- and dip-coating. In the present article, the design, manufacturing and performance of spray-coated pulsatile delivery platforms is thus reviewed.

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Research works printed but not linked: 76

  1. Bianchini, 1992, Influence of extrusion-spheronization processing on the physical properties of d-Indobufen pellets containing pH adjusters, Drug Dev. Ind. Pharm., 18, 1485, 10.3109/03639049209040854 · DOI
  2. Bianchini, 1993, d-Indobufen extended-release pellets prepared by coating with aqueous polymer dispersions, Drug Dev. Ind. Pharm., 19, 2021, 10.3109/03639049309069339 · DOI
  3. Bourgeois, 2005, Polymer colon drug delivery systems and their application to peptides, proteins, and nucleic acids, Am. J. Drug Deliv., 3, 171, 10.2165/00137696-200503030-00003 · DOI
  4. Bussemer, 2003, Formulation parameters affecting the performance of coated gelatin capsules with pulsatile release profiles, Int. J. Pharm., 267, 59, 10.1016/j.ijpharm.2003.07.008 · DOI
  5. Bussemer, 2003, A pulsatile drug delivery system based on rupturable coated hard gelatin capsules, J. Control. Release, 93, 331, 10.1016/j.jconrel.2003.08.012 · DOI
  6. Bussemer, 2001, Pulsatile drug-delivery systems, Crit. Rev. Ther. Drug Carrier Syst., 18, 433, 10.1615/CritRevTherDrugCarrierSyst.v18.i5.10 · DOI
  7. Bussemer, 2003, Evaluation of the swelling, hydration and rupturing properties of the swelling layer of a rupturable pulsatile drug delivery system, Eur. J. Pharm. Biopharm., 56, 261, 10.1016/S0939-6411(03)00070-5 · DOI
  8. Bussemer, 2003, Time-dependent mechanical properties of polymeric coatings used in rupturable pulsatile release dosage forms, Drug Dev. Ind. Pharm., 29, 623, 10.1081/DDC-120021311 · DOI
  9. Chacko, 1990, Non-invasive method for delivery of tracer substances or small quantities of other materials to the colon, Gut, 31, 106, 10.1136/gut.31.1.106 · DOI
  10. Conte, 1989, A new ibuprofen pulsed release oral dosage form, Drug Dev. Ind. Pharm., 15, 2583, 10.3109/03639048909052548 · DOI
  11. Conte, 1992, Ibuprofen delayed release dosage forms: a proposal for the preparation of an in vitro/in vivo pulsatile system, Eur. J. Pharm. Biopharm., 38, 209
  12. Dashevsky, 2004, Process and formulation variables affecting the performance of a rupturable capsule-based drug delivery system with pulsatile drug release, Drug Dev. Ind. Pharm., 30, 171, 10.1081/DDC-120028712 · DOI
  13. Davis, 1985, The design and evaluation of controlled release systems for the gastro-intestinal tract, J. Control. Release, 2, 27, 10.1016/0168-3659(85)90030-6 · DOI
  14. Del Curto, 2009, Preparation and evaluation of an oral delivery system for time-dependent colon release of insulin and selected protease inhibitor and absorption enhancer compounds, J. Pharm. Sci., 98, 4661, 10.1002/jps.21761 · DOI
  15. Del Curto, 2011, Oral delivery system for two-pulse colonic release of protein drugs and protease inhibitor/absorption enhancer compounds, J. Pharm. Sci., 100, 3251, 10.1002/jps.22560 · DOI
  16. Fan, 2001, An investigation of pulsatile release tablets with ethylcellulose and Eudragit L as film coating materials and cross-linked polyvinylpyrrolidone in the core tablets, J. Control. Release, 77, 245, 10.1016/S0168-3659(01)00508-9 · DOI
  17. Feng, 2008, Preparation and evaluation of a novel delayed-onset sustained-release system of propranolol hydrochloride, J. Pharm. Pharmacol., 60, 817, 10.1211/jpp.60.7.0002 · DOI
  18. Friend, 2005, New oral delivery systems for treatment of inflammatory bowel disease, Adv. Drug Deliv. Rev., 57, 247, 10.1016/j.addr.2004.08.011 · DOI
  19. Gazzaniga, 1995, Time-dependent oral delivery systems for colon targeting, S.T.P. Pharma Sci., 5, 83
  20. Gazzaniga, 2011, A novel injection-molded capsular device for oral pulsatile delivery based on swellable/erodible polymers, AAPS PharmSciTech, 12, 295, 10.1208/s12249-011-9581-6 · DOI
  21. Gazzaniga, 1994, Oral colon-specific drug delivery: design strategies, S.T.P. Pharma Prat., 4, 336
  22. Gazzaniga, 1994, Oral delayed-release system for colonic specific delivery, Int. J. Pharm., 108, 77, 10.1016/0378-5173(94)90418-9 · DOI
  23. Gazzaniga, 2008, Oral pulsatile delivery systems based on swellable hydrophilic polymers, Eur. J. Pharm. Biopharm., 68, 11, 10.1016/j.ejpb.2007.05.022 · DOI
  24. Gazzaniga, 1994, Oral Chronotopic® drug delivery systems: achievement of time and/or site specificity, Eur. J. Pharm. Biopharm., 40, 246
  25. Gupta, 1996, Pharmacokinetics of verapamil from an osmotic system with delayed onset, Eur. J. Pharm. Biopharm., 42, 74
  26. Hartman Kok, 2001, Development of particulate pulse-release formulations and their mathematical description, Powder Technol., 119, 33, 10.1016/S0032-5910(01)00402-8 · DOI
  27. Hartman Kok, 2000, A particulate pulse-release system and mathematical description with the Maxwell-Stefan theory, J. Control. Release, 66, 293, 10.1016/S0168-3659(99)00279-5 · DOI
  28. Hata, 1994, Development of a novel drug release system, time-controlled explosion system (TES). V. Animal pharmacodynamic study and human bioavailability study. Int, J. Pharm., 110, 1
  29. Haupt, 2002, The colon as a possible target for orally administered peptide and protein drugs, Crit. Rev. Ther. Drug Carrier Syst., 19, 499, 10.1615/CritRevTherDrugCarrierSyst.v19.i6.10 · DOI
  30. Kao, 1997, Lag time method to delay drug release to various sites in the gastrointestinal tract, J. Control. Release, 44, 263, 10.1016/S0168-3659(96)01529-5 · DOI
  31. Krögel, 1999, Floating or pulsatile drug delivery systems based on coated effervescent cores, Int. J. Pharm., 187, 175, 10.1016/S0378-5173(99)00189-1 · DOI
  32. Lin, 2008, Release characteristics and in vitro–in vivo correlation of pulsatile pattern for a pulsatile drug delivery system activated by membrane rupture via osmotic pressure and swelling, Eur. J. Pharm. Biopharm., 70, 289, 10.1016/j.ejpb.2008.03.021 · DOI
  33. Liu, 2009, Design and evaluation of pH-independent pulsatile release pellets containing isosorbide-5-mononitrate, Chem. Pharm. Bull., 57, 55, 10.1248/cpb.57.55 · DOI
  34. Maffione, 1993, High-viscosity HPMC as a film-coating agent, Drug Dev. Ind. Pharm., 19, 2043, 10.3109/03639049309069340 · DOI
  35. Maroni, 2013, Polymeric coatings for a multiple-unit pulsatile delivery system: Preliminary study on free and applied films, Int. J. Pharm., 440, 256, 10.1016/j.ijpharm.2012.05.075 · DOI
  36. Maroni, 2009, Feasibility, stability and release performance of a time-dependent insulin delivery system intended for oral colon release, Eur. J. Pharm. Biopharm., 72, 246, 10.1016/j.ejpb.2008.12.002 · DOI
  37. Maroni, 2005, Oral pulsatile drug delivery systems, Expert Opin. Drug Deliv., 2, 855, 10.1517/17425247.2.5.855 · DOI
  38. Maroni, 2012, Oral colon delivery of insulin with the aid of functional adjuvants, Adv. Drug Deliv. Rev., 64, 540, 10.1016/j.addr.2011.10.006 · DOI
  39. Maroni, 2010, Oral pulsatile delivery: rationale and chronopharmaceutical formulations, Int. J. Pharm., 398, 1, 10.1016/j.ijpharm.2010.07.026 · DOI
  40. Mohamad, 2006, pH-independent pulsatile drug delivery system based on hard gelatin capsules and coated with aqueous dispersion Aquacoat® ECD, Eur. J. Pharm. Biopharm., 64, 173, 10.1016/j.ejpb.2006.04.006 · DOI
  41. Mohamad, 2006, Development of pulsatile multiparticulate drug delivery system coated with aqueous dispersion Aquacoat® ECD, Int. J. Pharm., 318, 124, 10.1016/j.ijpharm.2006.03.022 · DOI
  42. Mohamad, 2007, In vitro and in vivo performance of a multiparticulate pulsatile drug delivery system, Drug Dev. Ind. Pharm., 33, 113, 10.1080/03639040601085433 · DOI
  43. Morita, 2000, Development of oral controlled release preparations, a PVA swelling controlled release system (SCRS). I. Design of SCRS and its release controlling factor, J. Control. Release, 63, 297, 10.1016/S0168-3659(99)00203-5 · DOI
  44. Morita, 2000, Development of oral controlled release preparations, a PVA swelling controlled release system (SCRS). II. In vitro and in vivo evaluation, J. Control. Release, 68, 115, 10.1016/S0168-3659(00)00244-3 · DOI
  45. Morita, 2003, Development of a new dissolution test method for an oral controlled release preparations, the PVA swelling controlled release system (SCRS), J. Control. Release, 90, 109, 10.1016/S0168-3659(03)00161-5 · DOI
  46. Murata, 1998, In vivo performance of time-controlled explosion system (TES) in GI physiology regulated dogs, Int. J. Pharm., 16, 161, 10.1016/S0378-5173(97)00347-5 · DOI
  47. Narisawa, 1994, An organic acid-induced sigmoidal release system for oral controlled-release preparations, Pharm. Res., 11, 111, 10.1023/A:1018910114436 · DOI
  48. Narisawa, 1996, An organic acid-induced sigmoidal release system for oral controlled-release preparations. 2. Permeability enhancement of Eudragit RS coating led by the physicochemical interactions with organic acid, J. Pharm. Sci., 85, 184, 10.1021/js950180o · DOI
  49. Narisawa, 1997, An organic acid-induced sigmoidal release system for oral controlled preparations. III. Elucidation of the anomalous drug release behaviour through osmotic pumping mechanism, Int. J. Pharm., 148, 85, 10.1016/S0378-5173(96)04834-X · DOI
  50. Narisawa, 1995, Drug release behavior in gastrointestinal tract of beagle dogs from multiple unit type rate-controlled or time-controlled release preparations coated with insoluble polymer-based film, J. Control. Release, 33, 253, 10.1016/0168-3659(94)00090-H · DOI
  51. Ozeki, 2004, Evaluation of novel one-step dry-coated tablets as a platform for delayed-release tablets, J. Control. Release, 95, 51, 10.1016/j.jconrel.2003.10.028 · DOI
  52. Pozzi, 1994, The Time Clock* system: a new oral dosage form for fast and complete release of drug after a predetermined lag time, J. Control. Release, 31, 99, 10.1016/0168-3659(94)90255-0 · DOI
  53. Prisant, 2001, Verapamil revisited. A transition in novel drug delivery systems and outcomes, Heart Dis., 3, 55
  54. Quadros, 1995, Evaluation of a novel colonic delivery device in vivo, S.T.P. Pharma Sci., 5, 77
  55. Saigal, 2009, Multiple-pulse drug delivery systems: setting a new paradigm for infectious disease therapy, Expert Opin. Drug Deliv., 6, 441, 10.1517/17425240902895972 · DOI
  56. Sangalli, 2004, Different HPMC viscosity grades as coating agents for an oral time and/or site-controlled delivery system: a study on process parameters and in vitro performances, Eur. J. Pharm. Sci., 22, 469, 10.1016/j.ejps.2004.05.002 · DOI
  57. Sangalli, 2001, In vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery, J. Control. Release, 73, 103, 10.1016/S0168-3659(01)00291-7 · DOI
  58. Santus, 1995, Osmotic drug delivery: a review of the patent literature, J. Control. Release, 35, 1, 10.1016/0168-3659(95)00013-X · DOI
  59. Sawada, 2003, Timed-release formulation to avoid drug-drug interaction between diltiazem and midazolam, J. Pharm. Sci., 92, 790, 10.1002/jps.10336 · DOI
  60. Schultz, 1997, A new multiparticulate delayed release system. Part I: dissolution properties and release mechanism, J. Control. Release, 47, 181, 10.1016/S0168-3659(97)01634-9 · DOI
  61. Schultz, 1997, A new multiparticulate delayed release system. Part II: coating formulation and properties of free films, J. Control. Release, 47, 191, 10.1016/S0168-3659(97)01635-0 · DOI
  62. Steed, 1997, The use of pharmacoscintigraphy to focus the development strategy for a novel 5-ASA colon targeting system (“Time Clock®” system), J. Control. Release, 49, 115, 10.1016/S0168-3659(97)00062-X · DOI
  63. Stubbe, 2004, “Programmed polymeric devices” for pulsed drug delivery, Pharm. Res., 21, 1732, 10.1023/B:PHAM.0000045223.45400.01 · DOI · Paper page
  64. Sungthongjeen, 2004, Development of pulsatile release tablets with swelling and rupturable layers, J. Control. Release, 95, 147, 10.1016/j.jconrel.2003.10.023 · DOI
  65. Ueda, 1994, Development of a novel drug release system, time-controlled explosion system (TES). I. Concept and design, J. Drug Target., 2, 35, 10.3109/10611869409015891 · DOI
  66. Ueda, 1994, Development of a novel drug delivery system, time-controlled explosion system (TES): IV. In vivo drug release behavior, J. Drug Target., 2, 133, 10.3109/10611869409015901 · DOI
  67. Ueda, 1994, Development of a novel drug release system, time-controlled explosion system (TES). III. Relation between lag time and membrane thickness, Chem. Pharm. Bull., 42, 364, 10.1248/cpb.42.364 · DOI
  68. Ueda, 1994, Development of a novel drug release system, time-controlled explosion system (TES). II. Design of multiparticulate TES and in vitro drug release properties, Chem. Pharm. Bull., 42, 359, 10.1248/cpb.42.359 · DOI
  69. Verma, 2002, Formulation aspects in the development of osmotically controlled oral drug delivery systems, J. Control. Release, 79, 7, 10.1016/S0168-3659(01)00550-8 · DOI
  70. White, 1995, Nocturnal dosing of a novel delivery system of verapamil for systemic hypertension, Am. J. Cardiol., 76, 375, 10.1016/S0002-9149(99)80104-0 · DOI
  71. Wilding, 1994, Enteric coated timed release systems for colonic targeting, Int. J. Pharm., 111, 99, 10.1016/0378-5173(94)90406-5 · DOI
  72. Yadav, 2011, Dual coating of swellable and rupturable polymers on Glipizide loaded MCC pellets for pulsatile delivery: Formulation design and in vitro evaluation, Int. J. Pharm., 419, 121, 10.1016/j.ijpharm.2011.07.026 · DOI
  73. Zhang, 2003, A novel pulsed-release system based on swelling and osmotic pumping mechanism, J. Control. Release, 89, 47, 10.1016/S0168-3659(03)00092-0 · DOI
  74. Zema, 2013, Injection-molded capsular device for oral pulsatile release: development of a novel mold, J. Pharm. Sci., 102, 489, 10.1002/jps.23371 · DOI
  75. Zema., 2012, Injection Molding and its application to drug delivery, J. Control. Release, 159, 324, 10.1016/j.jconrel.2012.01.001 · DOI
  76. Zema, 2007, Different HPMC viscosity grades as coating agents for an oral time and/or site-controlled delivery system: an investigation into the mechanisms governing drug release, J. Pharm. Sci., 96, 1527, 10.1002/jps.20802 · DOI

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Metadata

Authors
Maroni, A., Zema, L., Loreti, G., Palugan, L., & Gazzaniga, A.
Venue
International Journal of Pharmaceutics
Publisher
Elsevier BV
Published
2013-12
Volume
457
Issue
2
Pages
362-371
ISSN
0378-5173
DOI
10.1016/j.ijpharm.2013.03.010
Cited by
55
References
0
Language
en

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